SAN DIEGO, CA--(Marketwire - December 15, 2008) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its liquid stable enzymatic lithium test kit for the quantitative determination of lithium levels in blood samples.
Compared to existing methods, the new Diazyme lithium assay provides improved reagent stability and a reduced cost per test. The assay features excellent accuracy and precision and offers an extended reportable range of 0.1-3.0 mmole/L lithium which will reduce the need for re-testing elevated patient samples. The method also demonstrates no significant interference from indigenous ions and other interfering substances including hemoglobin, bilirubin, triglycerides and ascorbic acid. The assay can be applied to most common clinical chemistry analyzers, and application parameters are available from Diazyme.
Lithium has remained a first line treatment for the past fifty years and is considered by many physicians to be one of the corner stones for treating mode and affective disorders. Highly effective Lithium has been shown to be successful in improving both the manic and depressive symptoms in up to as many as 70 to 80% of these types of patients and is considered the drug of choice for reduction of suicide risk in bipolar illness.
"Diazyme's new enzymatic lithium assay provides a convenient and cost effective test method which will benefit laboratories, physicians and the patients they care for," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
Diazyme Laboratories is a division of General Atomics headquartered in La Jolla, California. Diazyme uses its enzyme platform technologies to develop low cost and uniform diagnostic products for clinical and research uses.
Products include diagnostic blood tests for liver disease, cardiac markers, diabetes, renal disease and electrolytes. Diazyme's enzyme technology and related products can be found in its website at www.diazyme.com.